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Regulating Homeostatic Plasticity and the Physiological Response to rTMS

NCT ID: NCT03309696

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2019-10-01

Brief Summary

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This device-study includes a pilot, physiological investigation of normal human subjects. The aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry as measured by EEG recording. Currently, the application of non-invasive neuromodulation is rarely guided by detailed knowledge of how neural activity is altered in the brain circuits that are targeted for intervention. This gap in knowledge is problematic for interpreting response variability, which is common. To address this gap, the current proposal aims to combine two forms of neuromodulation sequentially, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at different frequencies of rTMS. Homeostatic plasticity, the initial activation state of a targeted circuit, is a key determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD) Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. We aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The protocol included an exploratory aim to examine physiological changes in patients with tinnitus but this aim was not part of the pilot physiological investigation and it could not be completed due to funding limitations.

Detailed Description

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Background and Rationale: The current proposal aims to combine two forms of neuromodulation, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at two different frequencies (1Hz and 10Hz). Homeostatic plasticity, the initial activation state of a targeted circuit, is a theoretical determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD).Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. In a physiological investigation of health subjects, we aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The justification for this study is that controlling homeostatic plasticity can reduce subject variability and the knowledge gained can be used to optimize rTMS delivery. What is needed to move the field forward is a method for combining tDCS and rTMS and for measuring neuronal responses directly which we aim to establish in this study. The pilot study project will examine the targeted effects of neuromodulation in normal subjects. The brain regions targeted for intervention include auditory areas in the temporal cortex (TC) that process sounds and functionally connected regions of the dorsolateral frontal cortex (DLFC) that mediate sensory habituation. Due to funding limitations, only the 1 Hz rTMS condition could be initiated.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This prospective, experimental design includes a block randomized, blinded, sham controlled, mixed effects model with sequential assignment to treatment arms (1 or 10 Hz rTMS) and random assignment to the tDCS conditions within each arm. The order of the three experimental conditions within each arm is randomized.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS and 1 Hz rTMS delivered over TC

Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .

Group Type EXPERIMENTAL

sham tDCS and sham rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS

Intervention Type DEVICE

tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are active

tDCS and 10Hz rTMS delivered over TC

Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

Group Type EXPERIMENTAL

sham tDCS and sham rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS

Intervention Type DEVICE

tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are active

tDCS over DLFC and 1 Hz rTMS over TC

Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

Group Type EXPERIMENTAL

sham tDCS and sham rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS

Intervention Type DEVICE

tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are active

tDCS over DLFC and 10 Hz rTMS over TC

Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

Group Type EXPERIMENTAL

sham tDCS and sham rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS

Intervention Type DEVICE

tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS

Intervention Type DEVICE

Both combinations of tDCS and rTMS in this intervention are active

Interventions

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sham tDCS and sham rTMS

Both combinations of tDCS and rTMS in this intervention are sham.

Intervention Type DEVICE

sham tDCS and active rTMS

tDCS in this intervention is sham and rTMS is active

Intervention Type DEVICE

active tDCS and active rTMS

Both combinations of tDCS and rTMS in this intervention are active

Intervention Type DEVICE

Other Intervention Names

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transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS) transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS) transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Eligibility Criteria

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Inclusion Criteria

* complete the informed consent process
* men and women, age: 21-65 years
* negative pregnancy test (female subjects of childbearing age must take a pregnancy test).

Exclusion Criteria

* a personal or family history of epilepsy,
* severe head injury, aneurysm, stroke, previous cranial neurosurgery,
* sever or recurrent migraine headaches,
* metal implants in the head or neck, a pacemaker,
* pregnancy,
* medications that lower seizure threshold,
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Mennemeier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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206326

Identifier Type: -

Identifier Source: org_study_id